Observational Study of Patients With Subarachnoid Hemorrhage

Subarachnoid Hemorrhage Clinical Trial

— ProReSHA  

Official title:

A Prospective, Observational Registry of Patient With Subarachnoid Hemorrhage in Neurocritical Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02890004
• Other study ID #: 69HCL16_0561
• Status: Recruiting
• Phase: N/A
• First received: August 24, 2016
• Last updated: February 22, 2018
• Start date: February 16, 2017
• Est. completion date: March 16, 2020

Study information

• Verified date: February 2018
• Source: Hospices Civils de Lyon
• Contact: Frédéric DAILLER, MD
• Phone: 4 72 35 75 76
• Email: frederic.dailler[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This prospective, observational study aim to identify :

• Prognostic factor of patients with subarachnoid haemorrhage in neuro intensive care unit

• The impact of standard therapeutic used (surgery, embolization ; medical treatment of vasospasm ; treatment of complications like hyponatremia, stress myocardiopathy, …)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 16, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subarachnoid hemorrhage

Exclusion Criteria:

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Locations

Country	Name	City	State
France	Service de réanimation polyvalente neurologique Hôpital Neurologique HCL	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		at day 0
Primary	Survival		at 6 months
Primary	Survival		at 12 months
Secondary	Neurological outcome with the Glasgow Coma Scale (GCS) score		at day 0
Secondary	Neurological outcome with the Glasgow Coma Scale (GCS) score		at 6 months
Secondary	Neurological outcome with the Glasgow Coma Scale (GCS) score		at 12 months
Secondary	Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score		at day 0
Secondary	Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score		at 6 months
Secondary	Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score		at 12 months
Secondary	Brain lesions with MRI		at day 0
Secondary	Brain lesions with MRI		at 6 months
Secondary	Brain lesions with MRI		at 12 months
Secondary	delay of apparition of hyponatremia	Natremia in standard blood sample, Natremia is routinelly evaluated on alternte days, and more if required.	on alternte days after Day 0